TDMS Study 89010-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst PESTICIDE/FERTILIZER CONTAMINATION--MIXTURE 3 DATE: 10/18/04
EXPERIMENT: 89010 TEST: 01 TIME: 10:34:38
TEST TYPE: SUBCHRON 26-WEEK PAGE: 1
CONT: NO1-ES-95275 ROUTE: DOSED WATER NTP C#: C89010
PATHOLOGIST: D.R. FARNELL CAS: PESTFERTMIX3
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst PESTICIDE/FERTILIZER CONTAMINATION--MIXTURE 3 DATE: 10/18/04
EXPERIMENT: 89010 TEST: 01 TIME: 10:34:38
TEST TYPE: SUBCHRON 26-WEEK
CONT: NO1-ES-95275 ROUTE: DOSED WATER NTP C#: C89010
PATHOLOGIST: D.R. FARNELL CAS: PESTFERTMIX3
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF PESTICIDE/FERTILIZER CONTAMINATION--M
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Pituitary Gland Cyst
Pituitary Gland: Pars Distalis Hyperplasia Focal
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Accessory Adrenal Cortical Nodule
===============================================================
Date: 10/18/04 EXPERIMENT: 89010 TEST: 01 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/20 (0%) 1/20 (5%) 0/20 (0%) 0/20 (0%) 0/20 (0%) |
|POLY-3 RATE (b) | 0/11.27 1/12.14 0/11.27 0/11.27 0/11.27 |
|POLY-3 PERCENT (g) | 0.0% 8.2% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- 92 (I) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.721N P=0.500 (e) (e) (e) |
|POLY 3 | P=0.712N P=0.515 (e) (e) (e) |
|POLY 1.5 | P=0.716N P=0.509 (e) (e) (e) |
|POLY 6 | P=0.710N P=0.519 (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.723N (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.722N P=0.500 (e) (e) (e) |
|ORDER RESTRICTED | P=0.388N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/20 (10%) 0/20 (0%) 0/20 (0%) 0/20 (0%) 0/20 (0%) |
|POLY-3 RATE (b) | 2/13.02 0/11.27 0/11.27 0/11.27 0/11.27 |
|POLY-3 PERCENT (g) | 15.4% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 92 (I) --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.504N P=0.234N P=0.234N P=0.234N P=0.234N |
|POLY 3 | P=0.477N P=0.264N P=0.264N P=0.264N P=0.264N |
|POLY 1.5 | P=0.487N P=0.251N P=0.251N P=0.251N P=0.251N |
|POLY 6 | P=0.471N P=0.272N P=0.272N P=0.272N P=0.272N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.504N P=0.244N P=0.244N P=0.244N P=0.244N |
|ORDER RESTRICTED | P=0.022N* (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/04 EXPERIMENT: 89010 TEST: 01 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Heart: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/20 (5%) 0/20 (0%) 0/20 (0%) 0/20 (0%) 2/20 (10%) |
|POLY-3 RATE (b) | 1/12.14 0/11.27 0/11.27 0/11.27 2/12.14 |
|POLY-3 PERCENT (g) | 8.2% 0.0% 0.0% 0.0% 16.5% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|FIRST INCIDENCE | 92 (I) --- --- --- 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.094 P=0.500N P=0.500N P=0.500N P=0.500 |
|POLY 3 | P=0.098 P=0.515N P=0.515N P=0.515N P=0.500 |
|POLY 1.5 | P=0.095 P=0.509N P=0.509N P=0.509N P=0.500 |
|POLY 6 | P=0.101 P=0.519N P=0.519N P=0.519N P=0.500 |
|LOGISTIC REGRESSION| P=0.092 (e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.093 P=0.500N P=0.500N P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.077 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Heart: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/20 (0%) 0/20 (0%) 0/20 (0%) 0/20 (0%) 0/20 (0%) |
|POLY-3 RATE (b) | 0/11.27 0/11.27 0/11.27 0/11.27 0/11.27 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/04 EXPERIMENT: 89010 TEST: 01 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/20 (15%) 1/20 (5%) 3/20 (15%) 1/20 (5%) 0/20 (0%) |
|POLY-3 RATE (b) | 3/12.14 1/11.27 3/13.02 1/12.14 0/11.27 |
|POLY-3 PERCENT (g) | 24.7% 8.9% 23.1% 8.2% 0.0% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 2/10 (20%) 1/10 (10%) 0/10 (0%) |
|TERMINAL (d) | 2/10 (20%) 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 92 (I) 183 (T) 92 (I) 92 (I) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.132N P=0.301N P=0.667 P=0.304N P=0.120N |
|POLY 3 | P=0.133N P=0.321N P=0.643N P=0.293N P=0.116N |
|POLY 1.5 | P=0.130N P=0.312N P=0.653N P=0.295N P=0.113N |
|POLY 6 | P=0.136N P=0.327N P=0.635N P=0.292N P=0.119N |
|LOGISTIC REGRESSION| P=0.129N P=0.296N P=0.671N P=0.299N P=0.114N |
|COCH-ARM / FISHERS | P=0.129N P=0.302N P=0.669N P=0.302N P=0.115N |
|ORDER RESTRICTED | P=0.060N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/20 (10%) 2/20 (10%) 3/19 (16%) 2/20 (10%) 1/20 (5%) |
|POLY-3 RATE (b) | 2/11.27 2/11.27 3/12.89 2/11.27 1/12.14 |
|POLY-3 PERCENT (g) | 17.8% 17.8% 23.3% 17.8% 8.2% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 2/9 (22.2%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 2/10 (20%) 2/10 (20%) 1/10 (10%) 2/10 (20%) 0/10 (0%) |
|FIRST INCIDENCE | 183 (T) 183 (T) 92 (I) 183 (T) 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.319N P=0.707 P=0.480 P=0.707 P=0.500N |
|POLY 3 | P=0.293N P=0.706 P=0.566 P=0.706 P=0.473N |
|POLY 1.5 | P=0.301N P=0.704 P=0.532 P=0.704 P=0.483N |
|POLY 6 | P=0.290N P=0.707 P=0.586 P=0.707 P=0.466N |
|LOGISTIC REGRESSION| P=0.317N P=0.707 P=0.480 P=0.707 P=0.500N |
|COCH-ARM / FISHERS | P=0.316N P=0.698N P=0.475 P=0.698N P=0.500N |
|ORDER RESTRICTED | P=0.405N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/04 EXPERIMENT: 89010 TEST: 01 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/20 (0%) 0/20 (0%) 1/20 (5%) 2/20 (10%) 2/20 (10%) |
|POLY-3 RATE (b) | 0/11.27 0/11.27 1/11.27 2/13.02 2/12.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 8.9% 15.4% 16.5% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 1/10 (10%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/10 (10%) |
|FIRST INCIDENCE | --- --- 183 (T) 92 (I) 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.225 (e) P=0.500 P=0.234 P=0.240 |
|POLY 3 | P=0.248 (e) P=0.500 P=0.264 P=0.246 |
|POLY 1.5 | P=0.238 (e) P=0.500 P=0.251 P=0.240 |
|POLY 6 | P=0.254 (e) P=0.500 P=0.272 P=0.250 |
|LOGISTIC REGRESSION| P=0.223 (e) P=0.500 (e) P=0.234 |
|COCH-ARM / FISHERS | P=0.223 (e) P=0.500 P=0.244 P=0.244 |
|ORDER RESTRICTED | P=0.125 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/20 (5%) 3/20 (15%) 1/20 (5%) 3/20 (15%) 3/20 (15%) |
|POLY-3 RATE (b) | 1/11.27 3/12.14 1/12.14 3/12.14 3/12.14 |
|POLY-3 PERCENT (g) | 8.9% 24.7% 8.2% 24.7% 24.7% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 1/10 (10%) 1/10 (10%) 1/10 (10%) |
|TERMINAL (d) | 1/10 (10%) 2/10 (20%) 0/10 (0%) 2/10 (20%) 2/10 (20%) |
|FIRST INCIDENCE | 183 (T) 92 (I) 92 (I) 92 (I) 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.367 P=0.301 P=0.760 P=0.301 P=0.301 |
|POLY 3 | P=0.377 P=0.321 P=0.748N P=0.321 P=0.321 |
|POLY 1.5 | P=0.373 P=0.312 P=0.754N P=0.312 P=0.312 |
|POLY 6 | P=0.381 P=0.327 P=0.744N P=0.327 P=0.327 |
|LOGISTIC REGRESSION| P=0.365 P=0.296 P=0.766N P=0.296 P=0.296 |
|COCH-ARM / FISHERS | P=0.366 P=0.302 P=0.756N P=0.302 P=0.302 |
|ORDER RESTRICTED | P=0.284 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/04 EXPERIMENT: 89010 TEST: 01 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/20 (10%) 2/20 (10%) 0/20 (0%) 0/20 (0%) 3/20 (15%) |
|POLY-3 RATE (b) | 2/12.14 2/11.27 0/11.27 0/11.27 3/12.14 |
|POLY-3 PERCENT (g) | 16.5% 17.8% 0.0% 0.0% 24.7% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 1/10 (10%) 2/10 (20%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |
|FIRST INCIDENCE | 92 (I) 183 (T) --- --- 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.159 P=0.699 P=0.240N P=0.240N P=0.500 |
|POLY 3 | P=0.167 P=0.677 P=0.246N P=0.246N P=0.500 |
|POLY 1.5 | P=0.162 P=0.686 P=0.240N P=0.240N P=0.500 |
|POLY 6 | P=0.171 P=0.670 P=0.250N P=0.250N P=0.500 |
|LOGISTIC REGRESSION| P=0.157 P=0.704N P=0.234N P=0.234N P=0.500 |
|COCH-ARM / FISHERS | P=0.159 P=0.698N P=0.244N P=0.244N P=0.500 |
|ORDER RESTRICTED | P=0.174 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/20 (0%) 0/20 (0%) 0/20 (0%) 0/20 (0%) 0/20 (0%) |
|POLY-3 RATE (b) | 0/11.27 0/11.27 0/11.27 0/11.27 0/11.27 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/04 EXPERIMENT: 89010 TEST: 01 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/20 (20%) 1/20 (5%) 0/20 (0%) 0/20 (0%) 0/18 (0%) |
|POLY-3 RATE (b) | 4/13.02 1/11.27 0/11.27 0/11.27 0/10.14 |
|POLY-3 PERCENT (g) | 30.7% 8.9% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 2/10 (20%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | 92 (I) 183 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.243N P=0.175N P=0.062N P=0.062N P=0.075N |
|POLY 3 | P=0.208N P=0.204N P=0.062N P=0.062N P=0.077N |
|POLY 1.5 | P=0.216N P=0.188N P=0.056N P=0.056N P=0.071N |
|POLY 6 | P=0.205N P=0.216N P=0.067N P=0.067N P=0.083N |
|LOGISTIC REGRESSION| P=0.240N P=0.169N P=0.057N P=0.057N P=0.070N |
|COCH-ARM / FISHERS | P=0.241N P=0.171N P=0.053N P=0.053N P=0.066N |
|ORDER RESTRICTED | P=0.005N** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/19 (0%) 1/20 (5%) 1/20 (5%) 2/20 (10%) 0/20 (0%) |
|POLY-3 RATE (b) | 0/11.14 1/11.27 1/11.27 2/11.27 0/11.27 |
|POLY-3 PERCENT (g) | 0.0% 8.9% 8.9% 17.8% 0.0% |
|INT SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/10 (0%) 1/10 (10%) 1/10 (10%) 2/10 (20%) 0/10 (0%) |
|FIRST INCIDENCE | --- 183 (T) 183 (T) 183 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.382N P=0.500 P=0.500 P=0.234 (e) |
|POLY 3 | P=0.385N P=0.502 P=0.502 P=0.230 (e) |
|POLY 1.5 | P=0.382N P=0.505 P=0.505 P=0.235 (e) |
|POLY 6 | P=0.386N P=0.500 P=0.500 P=0.228 (e) |
|LOGISTIC REGRESSION| (e) P=0.500 P=0.500 P=0.234 (e) |
|COCH-ARM / FISHERS | P=0.379N P=0.513 P=0.513 P=0.256 (e) |
|ORDER RESTRICTED | P=0.360N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/04 EXPERIMENT: 89010 TEST: 01 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/20 (0%) 0/20 (0%) 0/20 (0%) 0/20 (0%) 2/18 (11%) |
|POLY-3 RATE (b) | 0/11.27 0/11.27 0/11.27 0/11.27 2/10.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 19.7% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/9 (22%) |
|FIRST INCIDENCE | --- --- --- --- 183 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.016 * (e) (e) (e) P=0.210 |
|POLY 3 | P=0.013 * (e) (e) (e) P=0.203 |
|POLY 1.5 | P=0.013 * (e) (e) (e) P=0.204 |
|POLY 6 | P=0.013 * (e) (e) (e) P=0.202 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.204 |
|COCH-ARM / FISHERS | P=0.016 * (e) (e) (e) P=0.218 |
|ORDER RESTRICTED | P=0.010 * (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/19 (0%) 1/20 (5%) 0/20 (0%) 0/20 (0%) 0/20 (0%) |
|POLY-3 RATE (b) | 0/11.14 1/11.27 0/11.27 0/11.27 0/11.27 |
|POLY-3 PERCENT (g) | 0.0% 8.9% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- 183 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.721N P=0.500 (e) (e) (e) |
|POLY 3 | P=0.722N P=0.502 (e) (e) (e) |
|POLY 1.5 | P=0.721N P=0.505 (e) (e) (e) |
|POLY 6 | P=0.722N P=0.500 (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.500 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.719N P=0.513 (e) (e) (e) |
|ORDER RESTRICTED | P=0.371N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/04 EXPERIMENT: 89010 TEST: 01 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/20 (15%) 3/20 (15%) 1/20 (5%) 1/20 (5%) 3/20 (15%) |
|POLY-3 RATE (b) | 3/13.02 3/13.02 1/12.14 1/12.14 3/13.89 |
|POLY-3 PERCENT (g) | 23.1% 23.1% 8.2% 8.2% 21.6% |
|INT SACRIFICE 1 (c)| 2/10 (20%) 2/10 (20%) 1/10 (10%) 1/10 (10%) 3/10 (30%) |
|TERMINAL (d) | 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 92 (I) 92 (I) 92 (I) 92 (I) 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.428 P=0.669 P=0.301N P=0.301N P=0.673 |
|POLY 3 | P=0.489 P=0.677N P=0.320N P=0.320N P=0.643N |
|POLY 1.5 | P=0.467 P=0.675 P=0.312N P=0.312N P=0.653N |
|POLY 6 | P=0.502 P=0.677 P=0.326N P=0.326N P=0.637N |
|LOGISTIC REGRESSION| P=0.427 P=0.673N P=0.296N P=0.296N P=0.678N |
|COCH-ARM / FISHERS | P=0.429 P=0.669N P=0.302N P=0.302N P=0.669N |
|ORDER RESTRICTED | P=0.424N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|INT SACRIFICE 1 (c)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 10/18/04 EXPERIMENT: 89010 TEST: 01 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/20 (20%) 5/20 (25%) 5/20 (25%) 6/20 (30%) 3/20 (15%) |
|POLY-3 RATE (b) | 4/12.14 5/13.02 5/13.02 6/13.02 3/12.14 |
|POLY-3 PERCENT (g) | 32.9% 38.4% 38.4% 46.1% 24.7% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 2/10 (20%) 2/10 (20%) 2/10 (20%) 1/10 (10%) |
|TERMINAL (d) | 3/10 (30%) 3/10 (30%) 3/10 (30%) 4/10 (40%) 2/10 (20%) |
|FIRST INCIDENCE | 92 (I) 92 (I) 92 (I) 92 (I) 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.270N P=0.500 P=0.500 P=0.357 P=0.500N |
|POLY 3 | P=0.288N P=0.551 P=0.551 P=0.395 P=0.500N |
|POLY 1.5 | P=0.279N P=0.532 P=0.532 P=0.379 P=0.500N |
|POLY 6 | P=0.295N P=0.563 P=0.563 P=0.406 P=0.500N |
|LOGISTIC REGRESSION| P=0.268N P=0.500 P=0.500 P=0.354 P=0.500N |
|COCH-ARM / FISHERS | P=0.270N P=0.500 P=0.500 P=0.358 P=0.500N |
|ORDER RESTRICTED | P=0.409N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|INT SACRIFICE 1 (c)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 10/18/04 EXPERIMENT: 89010 TEST: 01 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Ultimobranchial Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/20 (0%) 2/20 (10%) 1/20 (5%) 3/20 (15%) 1/20 (5%) |
|POLY-3 RATE (b) | 0/11.27 2/12.14 1/12.14 3/13.89 1/11.27 |
|POLY-3 PERCENT (g) | 0.0% 16.5% 8.2% 21.6% 8.9% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 1/10 (10%) 3/10 (30%) 0/10 (0%) |
|TERMINAL (d) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|FIRST INCIDENCE | --- 92 (I) 92 (I) 92 (I) 183 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.582N P=0.240 P=0.500 P=0.111 P=0.500 |
|POLY 3 | P=0.605N P=0.246 P=0.515 P=0.147 P=0.500 |
|POLY 1.5 | P=0.596N P=0.240 P=0.509 P=0.132 P=0.500 |
|POLY 6 | P=0.611N P=0.250 P=0.519 P=0.158 P=0.500 |
|LOGISTIC REGRESSION| P=0.583N P=0.234 (e) P=0.105 P=0.500 |
|COCH-ARM / FISHERS | P=0.582N P=0.244 P=0.500 P=0.115 P=0.500 |
|ORDER RESTRICTED | P=0.215 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Ultimobranchial Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/20 (15%) 2/20 (10%) 2/20 (10%) 0/20 (0%) 0/20 (0%) |
|POLY-3 RATE (b) | 3/13.89 2/12.14 2/12.14 0/11.27 0/11.27 |
|POLY-3 PERCENT (g) | 21.6% 16.5% 16.5% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 3/10 (30%) 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/10 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 92 (I) 92 (I) 92 (I) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.139N P=0.500N P=0.500N P=0.111N P=0.111N |
|POLY 3 | P=0.144N P=0.565N P=0.565N P=0.147N P=0.147N |
|POLY 1.5 | P=0.140N P=0.542N P=0.542N P=0.132N P=0.132N |
|POLY 6 | P=0.148N P=0.579N P=0.579N P=0.158N P=0.158N |
|LOGISTIC REGRESSION| P=0.137N P=0.500N P=0.500N P=0.105N P=0.105N |
|COCH-ARM / FISHERS | P=0.139N P=0.500N P=0.500N P=0.115N P=0.115N |
|ORDER RESTRICTED | P=0.065N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/04 EXPERIMENT: 89010 TEST: 01 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|INT SACRIFICE 1 (c)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 0.1X 1X 10X 100X |
| | CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/20 (20%) 4/20 (20%) 6/20 (30%) 4/20 (20%) 5/20 (25%) |
|POLY-3 RATE (b) | 4/12.14 4/13.89 6/14.76 4/12.14 5/14.76 |
|POLY-3 PERCENT (g) | 32.9% 28.8% 40.6% 32.9% 33.9% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 3/10 (30%) 4/10 (40%) 1/10 (10%) 4/10 (40%) |
|TERMINAL (d) | 3/10 (30%) 1/10 (10%) 2/10 (20%) 3/10 (30%) 1/10 (10%) |
|FIRST INCIDENCE | 92 (I) 92 (I) 92 (I) 92 (I) 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.523 P=0.650 P=0.361 P=0.655 P=0.500 |
|POLY 3 | P=0.604N P=0.577N P=0.496 P=0.666 P=0.638 |
|POLY 1.5 | P=0.590 P=0.606N P=0.444 P=0.662 P=0.590 |
|POLY 6 | P=0.586N P=0.559N P=0.527 P=0.667 P=0.649N |
|LOGISTIC REGRESSION| P=0.523 P=0.654N P=0.358 P=0.658N P=0.500 |
|COCH-ARM / FISHERS | P=0.523 P=0.653N P=0.358 P=0.653N P=0.500 |
|ORDER RESTRICTED | P=0.656 (e) (e) (e) (e) |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(g) Poly-3 adjusted lifetime tumor incidence.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).